CD19/CD20-directed CAR-T cells for Non-Hodgkin's Lymphoma

City of Hope Medical Center, Duarte, CA
Non-Hodgkin's LymphomaCD19/CD20-directed CAR-T cells - Biological
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new CAR-T therapy that targets two proteins found on B-cells to treat adults with B-cell non-Hodgkin lymphoma who have relapsed or are refractory to other treatments.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Throughout the first 12 months follow up period completion (3 years)

Year 3
Duration of response (DOR)
Incidence of Adverse Events [Safety and Tolerability]
Overall response rate (ORR)
Overall survival (OS)
Presence of replication competent lentivirus (RCL)
Progression-free survival (PFS)
Time to response (TTR)
Month 12
The recommended Phase 2 dose (RP2D) of C-CAR039 in patients with r/r B-NHL
Up to 24 months
AUCs (area under the curve)
Anti-drug (C-CAR039) antibody
C-CAR039 CAR copy number by qPCR in peripheral blood
Cmax (maximal plasma concentration)
Tmax (Time to reach the maximal plasma concentration)
up to 24 months
Blood cytokines changes
The B cell percentage changes and CD19/CD20 expression changes in blood

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

C-CAR039
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: CD19/CD20-directed CAR-T cells · No Placebo Group · Phase 1

C-CAR039
Biological
Experimental Group · 1 Intervention: CD19/CD20-directed CAR-T cells · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the first 12 months follow up period completion (3 years)

Who is running the clinical trial?

City of Hope Medical CenterOTHER
535 Previous Clinical Trials
2,249,939 Total Patients Enrolled
Cellular Biomedicine Group, Inc.Lead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
Cellular Biomedicine Group Ltd.Lead Sponsor
29 Previous Clinical Trials
979 Total Patients Enrolled
John Baird, M.D.Principal InvestigatorCity of Hope Medical Center

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

How many participants are engaging in this clinical experiment?

"Affirmative. Clinicaltrials.gov's information reveals that this clinical trial, first advertised on August 9th 2022, is still enrolling patients. The study aims to enrol 15 people from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Does this clinical experiment currently have an open enrollment period?

"Correct. According to the information found on clinicaltrials.gov, this medical trial started recruiting participants from August 9th 2022 and is still actively doing so. The research requires 15 people at a single site to be enrolled in order for it to succeed." - Anonymous Online Contributor

Unverified Answer

Has the FDA authorized CD19/CD20-directed CAR-T cells to be utilized by medical professionals?

"Our research team judged the safety of CD19/CD20-directed CAR-T cells to be a 1 due to being in Phase 1, which means there is only preliminary data that supports its efficacy and limited information regarding its safety." - Anonymous Online Contributor

Unverified Answer

What outcomes is this study aiming to manifest?

"This clinical trial's primary outcome, tracked over a 12-month time frame, will be the incidence of Adverse Events [Safety and Tolerability]. Secondary objectives include monitoring C-CAR039 CAR copy number in peripheral blood with qPCR, measuring maximal plasma concentration of C-CAR039 in peripheral blood (Cmax), and estimating overall response rate by determining both complete response (CR) rate and partial response (PR) rates." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.